TGA medicine labelling and packaging review
24 May 2012
- About this review
- Have your say
- Glossary of terms
- Prominence of active ingredients on medicine labels
- Look-alike and sound-alike medicine brand names and look-alike packaging and branding
- Standardised information format: the Medicine Information Box
- Dispensing label space
- Blister strip labelling
- Small containers
- Pack inserts
- Labels and packaging advisory committee
- Appendix 1: Consolidated list of recommendations
- Appendix 2: Reference list
- Appendix 3: Organisations represented on the external reference group
- Appendix 4: Questions & answers about the labelling and packaging review
- Medicines labelling and packaging review: Public submissions
- Initial analysis of submissions and proposed next steps in the review process
This consultation closed on 24 August 2012
The TGA sought comments on recommendations to change the presentation of information on the labels and packages of medicines. The recommendations cover:
- products purchased from a supermarket or a pharmacy without a prescription, or
- products purchased following a consultation with a health professional, usually with a prescription.
Improvements to the visual presentation of the labels and packages of medicines are aimed to enable the safe use of medicines by consumers.
Feedback received through the consultation process will help the TGA develop appropriate regulatory solutions to address widely recognised consumer safety risks associated with the current regulations for the labelling and packaging of medicines.
Submissions may address any, or all, of the general questions at the end of each section. You may also provide additional information on issues not asked in the questions.
In addition to responses to the general questions for the proposed changes, the TGA sought specific information from industry, including responses that address:
- Whether or not you, or your organisation, support the proposed changes. If a change is not supported, please may make suggestions for an acceptable alternative and provide rationales for the commentary.
- An assessment of how the proposed change will impact on you or your organisation. That is, what are the likely benefits or costs to you or your organisation (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.
Submissions will be acknowledged as they are received.
At the close of the consultation period, the TGA will collate and analyse submissions on matters that are within the scope of this review.
The TGA will draft a Therapeutic Goods Order that reflects the outcomes of this consultation and, in accordance with the Best practice regulation handbook1, will conduct a consultation to determine the economic impact of the proposed changes on the medicines industry.
At the completion of these other consultation processes, which also includes consultation with the Therapeutic Goods Committee, a revised Therapeutic Goods Order will be released. It will be determined at this time if any other regulatory amendments or instruments are required.
Updates on progress of the review and expected timeframes will be provided on the TGA website.
- The Best practice regulation handbook is a publication of the Department of Finance and Deregulation and describes consultation processes that Australian government agencies must conduct when implementing regulatory changes that are not minor or routine. For more information visit <http://www.finance.gov.au/obpr/about/>
All submissions received will be placed on the TGA's Internet site, unless marked confidential. Any confidential material contained within your submission should be provided under a separate cover and clearly marked "IN CONFIDENCE". Reasons for a claim to confidentiality must be included in the space provided on the TGA submission coversheet.
For submission made by individuals, all personal details, other than your name, will be removed from your submission before it is published on the TGA's Internet site.
In addition, a list of parties making submissions will be published. If you do not wish to be identified with your submission you must specifically request this in the space provided on the submission coversheet.
The TGA has conducted a review of the requirements for labels and packaging of medicines marketed in Australia. The proposed changes were developed in conjunction with an external reference group representing consumers, health care professionals and industry. These issues were determined through collation of previous consultations on labelling requirements together with feedback and reports from consumer groups, industry and consultation with key stakeholders.
Web page last updated: Monday, 5 November 2012